Job Description: Manager, Regulatory Affairs (IVD) – CONFIDENTIAL SEARCH

Location: Greater Vancouver On-Site
Reporting to: Director
Salary Range: $90,000 to $120,000 per annum

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Position Overview:
A growing organization in the medical diagnostics sector is seeking a Manager, Regulatory Affairs (IVD) to lead regulatory projects, ensure compliance with global requirements, and support product registrations across multiple jurisdictions. This role involves managing cross-functional teams, mentoring junior staff, and developing regulatory strategies to achieve market access for innovative IVD products.

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Key Responsibilities:

• Regulatory Leadership:
  • Lead preparation and submission of global regulatory filings (e.g., De Novo, PMA, 510(k)).
  • Act as the primary liaison with regulatory agencies.
• Compliance & Strategy:
  • Develop and implement strategies to meet global standards (FDA, EU IVDR, Health Canada, PMDA, NMPA, HAS and TGA, etc.).
  • Monitor regulatory changes to assess impacts on products.
• Collaboration & Mentorship:
  • Partner with R&D, Quality, and Operations teams to ensure market readiness.
  • Mentor junior staff and review work for compliance.
• Process Improvement:
  • Optimize regulatory workflows and documentation processes.

Qualifications:

• Education: Bachelor’s in Life Sciences, Biotechnology, or related field (advanced degree preferred).
• Experience:
  • 8+ years in Regulatory Affairs, focusing on IVDs or medical devices.
  • Proven experience with global submissions (e.g.,
  • • De Novo, PMA, 510(k)), Canada, Europe (IVDR), Japan, China, Singapore, Australia).
• Skills:
  • Strong understanding of global regulatory standards.
  • Exceptional organizational, problem-solving, and communication skills.
  • Authority to work in Canada.

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What’s Offered:
This is an exciting opportunity to join a dynamic organization driving impactful diagnostic solutions.

To Apply:
For a full job description contact Carla Campbell, Executive Talent Consultant, TalentSphere – Life Sciences, at ccampbell@talentsphere.ca.  To apply, please use the TalentSphere job board.

TSSHP LI-TS1
Job Posting ID: #16567019

Thank you for your interest in this job posting.

We look forward to hearing from you.

TalentSphere Staffing Solutions
talentsphere.ca

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